TPLC - Total Product Life Cycle

show TPLC since

Device	lamp, infrared, therapeutic heating
Product Code	ILY
Regulation Number	890.5500
Device Class	2

Premarket Reviews
Manufacturer	Decision
AESTHETIC TECHNOLOGY LTD
	SUBSTANTIALLY EQUIVALENT	1
CYTONSYS INC
	SUBSTANTIALLY EQUIVALENT	1
LIGHT TREE VENTURES EUROPE B.V.
	SUBSTANTIALLY EQUIVALENT	1
LTBIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	16	16
Adverse Event Without Identified Device or Use Problem	5	5
Improper or Incorrect Procedure or Method	3	3
Patient-Device Incompatibility	3	3
Use of Device Problem	2	2
Insufficient Information	2	2
Overheating of Device	2	2
Temperature Problem	1	1
Noise, Audible	1	1
Device-Device Incompatibility	1	1
Device Operational Issue	1	1
Break	1	1
Electrical /Electronic Property Problem	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Emits Odor	1	1
Power Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	12	12
Partial thickness (Second Degree) Burn	5	5
No Clinical Signs, Symptoms or Conditions	4	4
No Known Impact Or Consequence To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Superficial (First Degree) Burn	2	2
Inflammation	2	2
Blister	2	2
Rash	2	2
Insufficient Information	2	2
Radiation Burn	2	2
Headache	2	2
Complaint, Ill-Defined	1	1
Radiation Exposure, Unintended	1	1
Nausea	1	1
Red Eye(s)	1	1
Dizziness	1	1
Skin Inflammation/ Irritation	1	1
Localized Skin Lesion	1	1
Skin Inflammation	1	1
Numbness	1	1
Unspecified Eye / Vision Problem	1	1
Viral Infection	1	1
Pain	1	1
Dyspnea	1	1
Scar Tissue	1	1
Reaction	1	1
Undesired Nerve Stimulation	1	1
Swelling/ Edema	1	1
Unspecified Respiratory Problem	1	1
Convulsion/Seizure	1	1
Sore Throat	1	1
Swollen Lymph Nodes/Glands	1	1
Full thickness (Third Degree) Burn	1	1
Bruise/Contusion	1	1
Skin Burning Sensation	1	1